About this trial
The study aims to evaluate the effect of the royal jelly on inflammation and oxidative stress in participants with systemic arterial hypertension. A longitudinal double-blind randomized clinical trial will be carried out, involving hypertensive participants for two months.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Diagnosis of stage 1 hypertension
Regular treatment for more than 6 months
No changes in medication doses during the last 3 months
Disqualifiers
Autoimmune diseases
Infectious diseases
Diabetes
Chronic kidney disease
Trial design
Parallel
Treatments tested in this trial
Royal Jelly
Dietary supplementParticipants will receive 2 capsules per day, providing the dosage of 300mg of royal jelly for 2 months (8 weeks).
Placebo
Dietary supplementThe placebo group will receive 2 capsules per day (containing microcrystalline cellulose and magnesium stearate in colored gelatin capsules capable of masking the appearance of the internal content), at the same time for 2 months.
Treatment groups
Trial outcomes
Primary outcomes
Change of inflammatory transcripton factor
Assessment of NFkB expression levels in blood samples collected at baseline and after 8 weeks of supplementation.
Secondary outcomes
Change in interleukin-6 (IL-6) levels
Assessment of changes in serum interleukin-6 (IL-6) levels after supplementation.
Change in tumor necrosis factor-alpha (TNF-α) levels
Assessment of changes in serum tumor necrosis factor-alpha (TNF-α) levels after supplementation.
Change in Nrf2 expression
Assessment of changes in Nrf2 expression after supplementation.
Change in C-reactive protein (CRP) levels
Assessment of changes in serum C-reactive protein (CRP) levels after supplementation.
Sponsors and contacts
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